SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Improve Stroke Outcomes
NCT06397937 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 275
Last updated 2026-04-08
Summary
Primary Goal:
To test the hypothesis that among stroke patients 18-75 years with ≥3 SDOH risk factors, SHIFT will improve: (1) functional outcomes as measured by the SIS (Primary Outcome), (2) physiological outcomes as measured by changes in blood pressure and cognition, (secondary outcomes) and (3) epigenetic allostatic load biomarkers (exploratory outcome) such as DNA methylation (DNAm) and telomere length, at 6 months and 1-year post-stroke, compared with usual care (UC).
Conditions
- Stroke
- Social Determinants of Health
Interventions
- BEHAVIORAL
-
SHIFT team intervention
The SHIFT team, comprising a community health worker (CHW), community social worker (CHW), and community nurse (CN) will visit the participant starting within 72 hours of hospital discharge and provide social service referrals related to food insecurity, housing, immigration, and employment, and assist with medical appointment preparation (CHW), deliver individualized counseling focused on coping skills, reducing caregiver strain, and the psychological distress associated with experiences of racism and SDOH (CSW), and address health literacy and review of treatment goals and medications (CN).
Sponsors & Collaborators
-
National Institute of Neurological Disorders and Stroke (NINDS)
collaborator NIH - lead OTHER
Principal Investigators
-
Olajide Williams, MD · Columbia University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-15
- Primary Completion
- 2030-01-31
- Completion
- 2030-01-31
Countries
- United States
Study Locations
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